BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1747559 · Received July 1, 2010

    Report

    Report Number
    2024168-2010-01308
    Event Type
    Injury
    Date Received
    July 1, 2010
    Date of Event
    May 21, 2010
    Report Date
    June 9, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE STENTS REMAIN IN THE PATIENT. THE STENT DELIVERY SYSTEMS WERE DISCARDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE 2.5 X 28 MM XIENCE V (PART 1009545-28, LOT 9051261), 3.0 X 28 MM XIENCE V (PART 1009541-28, LOT 8081561), INDICATED ARE BEING FILED UNDER THIS MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: STENOSIS REQUIRING INTERVENTION. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE, AFTER THE PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT ON (B) (6) 2009, THE PATIENT UNDERWENT STENTING IN THE PREDILATED, MODERATELY CALCIFIED RIGHT POSTERIOR DESCENDING ARTERY LESION WITH THREE XIENCE V STENTS. ON (B) (6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR INCREASING SHORTNESS OF BREATH AND OTHER UNSPECIFIED SYMPTOMS THAT WERE SIMILAR TO THOSE EXPERIENCED PRIOR TO THE INDEX PROCEDURE. A NUCLEAR STRESS TEST SHOWED POSSIBLE ISCHEMIA IN THE INFERIOR WALL RESULTING IN A DIAGNOSTIC CORONARY ANGIOGRAPHY AND PERCUTANEOUS CORONARY INTERVENTION IN THE TARGET LESION. AN ECG AND CARDIAC ENZYMES SHOWED NO MYOCARDIAL INFARCTION. THE PATIENT'S CONDITION RESOLVED ON (B) (6) 2010, AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8082761

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R LOT 9051261| 3.0 X 28 MM XIENCE V, PART 1009541-28, LOT 8081561| VESSEL CLOSURE: MYNX CLOSURE SYSTEM| STENT: 2.5 X 28MM XIENCE V, PART 1009545-28